Multiple Clip Deployment Magazine

ABSTRACT

An apparatus for deployment of multiple hemostatic clips, comprises a shaft connected to a handle and a control linkage operatively connected to the handle in combination with a magazine disposed at a distal end of the shaft, the magazine containing a plurality of clips arranged in a chain rotatable within the magazine, wherein a proximal-most one of the clips is coupled to the control linkage, a distal portion of the magazine being contoured to permit opening of a distal-most one of the clips during a distal stroke of the control linkage, and to assist closing and locking of the distal-most clip during a proximal stroke of the control linkage, the magazine including an expanded chamber sized to allow opening in any rotational orientation of a next clip located immediately proximal to the distal-most clip to a degree sufficient to disengage the distal-most clip. A method for deploying multiple hemostatic clips, comprises positioning a distal end of a magazine containing a clip chain over selected target tissue and actuating a control link of the magazine in a distal stroke to open and distally translate a distal-most clip of the clip chain in combination with orienting the open distal-most clip in a desired orientation to grasp the target tissue and actuating the control link in a proximal stroke to close and lock the distal-most clip over the target tissue. The control link is further actuated in the proximal stroke to move a next clip immediately proximal to the distal-most clip into an expanded portion of the magazine sized to allow the next clip to open to a degree sufficient to release the distal-most clip regardless of a circumferential orientation of the next clip.

BACKGROUND

Endoscopic procedures to treat abnormal pathologies of thegastro-intestinal (“GI”) canal, of the biliary tree, of the vascularsystem and of various other body lumens are becoming increasinglycommon. An endoscope is basically a hollow tube placed at a desiredlocation within the body to facilitate access to the relevant body ductsand lumens, etc. The endoscope itself cannot carry out many of therequired procedures. To that end, the endoscope is fitted with a lumen,or internal channel, which permits the user to insert various medicaldevices therethrough to the location that requires treatment. Once thedistal end of the inserted device has reached the tissue to be treated,it can be manipulated using controls which remain outside the body.

An hemostatic clipping tool is one of the devices which may be insertedthrough an endoscope so that treatment may be carried out. Hemostaticclips are deployed from the clipping tool and are used to stop internalbleeding by clamping together the edges of a wound. The clipping toolcomplete with clips attached to its distal end is inserted through theendoscope to the location of the bleeding. A clip is then remotelymanipulated into position over the site of bleeding, clamped over thewound and detached from the tool. After a number of clips sufficient tostop the bleeding has been deployed, the tool is withdrawn from thepatient's body through the endoscope. The size and shape of the clipsand of the clipping tool are limited by the inner diameter of theendoscope's lumen, thus placing constraints on the design of the clippositioning and release mechanisms.

One challenge facing the endoscope operator is to properly position thehemostatic clips over the wound, so that closing the clips over thetissue will be effective in stopping the bleeding. If a clip is deployedimproperly, additional clips may be required to stop the bleedingextending the time required for and the complexity of the procedure andleaving additional medical devices within the patient. It is thusbeneficial if the clipping tool allows the user to orient the clips asrequired during deployment. It is also important for the device operatorto be certain of the status of the clip during the deployment operation.For example, before withdrawing the tool from the endoscope, theoperator should have positive indication that a clip has fully deployed,and has been released from the tool. At the same time the design of thetool should ensure that clips are fully released after they have beenclosed over the tissue.

SUMMARY OF THE INVENTION

In one aspect, the present invention is directed to an apparatus fordeployment of multiple hemostatic clips, comprising a shaft connected toa handle and a control linkage operatively connected to the handle incombination with a magazine disposed at a distal end of the shaft, themagazine containing a plurality of clips arranged in a chain rotatablewithin the magazine, wherein a proximal-most one of the clips is coupledto the control linkage. A distal portion of the magazine is contoured topermit opening of a distal-most one of the clips during a distal strokeof the control linkage and to assist closing and locking of thedistal-most clip during a proximal stroke of the control linkage. Themagazine includes an expanded chamber sized to allow opening in anyrotational orientation of a next clip located immediately proximal tothe distal-most clip to a degree sufficient to disengage the distal-mostclip from the clip chain.

The present invention is further directed to a method for deployingmultiple hemostatic clips, comprising positioning a distal end of amagazine containing a clip chain over selected target tissue andactuating a control link of the magazine in a distal stroke to open anddistally translate a distal-most clip of the clip chain in combinationwith orienting the open distal-most clip in a desired orientation tograsp the target tissue and actuating the control link in a proximalstroke to close and lock the distal-most clip over the target tissue.The control link is further actuated in the proximal stroke to move anext clip immediately proximal to the distal-most clip into an expandedportion of the magazine sized to allow the next clip to open to a degreesufficient to release the distal-most clip from the clip chainregardless of a circumferential orientation of the next clip and thedistal-most clip is released by partially opening the next clip.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic side view of a clipping device according to anembodiment of the present invention with FIG. 1A showing a detail viewof an exemplary clip assembly;

FIG. 2 is a schematic side view of the embodiment shown in FIG. 1, witha outer sheath;

FIG. 3 is a cut away side view of the shaft section according to anembodiment of the present invention;

FIG. 4 is a cross sectional view of the shaft section shown in FIG. 3;

FIG. 5 is a detail view of the distal end of the control wire accordingto an embodiment of the present invention;

FIG. 6 is a perspective view of an outer sheath according to anembodiment of the present invention;

FIG. 7 is an cross sectional exploded view of the handle of the outersheath shown in FIG. 6;

FIG. 8 is a perspective view of an outer sheath lock according to anembodiment of the present invention;

FIG. 9 is a cross sectional side view of a distal end of a clippingdevice according to an embodiment of the present invention;

FIG. 10 is a cross sectional top view of a distal end of the clippingdevice shown in FIG. 9;

FIG. 12 is a top view of the clip arms according to an embodiment of thepresent invention;

FIG. 13 is a perspective view of the clip arms shown in FIG. 12,according to an embodiment of the present invention;

FIG. 14 is a perspective view of a capsule according to an embodiment ofthe present invention;

FIG. 15 is a cross sectional side view of the of the capsule shown inFIG. 14;

FIG. 16 is a top view of the distal end of a clipping device accordingto an embodiment of the present invention;

FIG. 17 is a side view of the distal end shown in FIG. 16;

FIG. 18 is a perspective view of a clip arm according to an embodimentof the present invention;

FIG. 19 is a side view of the clip arm shown in FIG. 18;

FIG. 20 is a top view of the clip arm shown in FIG. 18;

FIG. 21 is a perspective view of a bushing according to an embodiment ofthe present invention;

FIG. 22 is a cross sectional side view of the bushing shown in FIG. 21;

FIG. 23 is a perspective view of a wire stop according to an embodimentof the present invention;

FIG. 24 is a schematic side view of a clip assembly detached from abushing, according to an embodiment of the present invention;

FIG. 25 is a side view of a tension member according to an embodiment ofthe present invention;

FIG. 26 is a top view of the tension member shown in FIG. 25;

FIG. 27 is a top view of a yoke according to an embodiment of thepresent invention;

FIG. 28 is a perspective view of the yoke shown in FIG. 27;

FIG. 29 is a top view of a yoke with a control wire according to anembodiment of the present invention;

FIG. 30 shows a detail of a connection between a control link and a clipchain according to an embodiment of the invention;

FIG. 31 shows a perspective view of an individual hemostatic clip of aclip chain according to an embodiment of the invention;

FIG. 32 shows a side elevation view of a clip chain according to anembodiment of the invention;

FIG. 33 shows a perspective view of a second embodiment of a clip for aclip chain according to the invention;

FIG. 34 shows a perspective view of a third embodiment of a clip for aclip chain according to the invention;

FIG. 35 shows a perspective view of the clip chain shown in FIG. 32;

FIG. 36 shows a perspective view of a clip magazine according to anembodiment of the invention;

FIG. 37 shows a distal end detail of the clip magazine shown in FIG. 36;

FIG. 38 shows a cut away perspective view of a clip chain loaded in aclip magazine according to an embodiment of the invention;

FIG. 39 shows the clip chain of FIG. 38 being pushed out of the clipmagazine;

FIG. 40 shows the clip chain of FIG. 38 yet further out of the clipmagazine with one clip deployed;

FIG. 41 shows a distal end detail of the clip magazine shown in FIG. 39;

FIG. 42 shows the clip chain of FIG. 38 with a clip deployed andreleased from the clip chain;

FIG. 43 is a schematic diagram showing a detail of the magazine an clipsaccording to an embodiment of the present invention;

FIG. 44 is a cut-away diagram showing two clips in the magazine in apre-deployment configuration;

FIG. 45 is a cut-away diagram showing one of the clips shown in FIG. 44with open clip arms;

FIG. 46 is a cut-away diagram showing one of the clips of FIG. 44 beinglocked in the closed configuration;

FIG. 47 is a cut-away diagram showing one of the clips of FIG. 44 beingdisconnected from the other clip; and

FIG. 48 is a cut-away diagram showing one of the clips of FIG. 44deployed from the magazine.

DETAILED DESCRIPTION

Hemostatic clips are used routinely to stop bleeding from openingscreated during surgery as well as wounds resulting from other trauma totissues. In the simplest form, these clips grasp the tissue surroundinga wound and bring the wound's edges together, to allow the naturalscarring process to heal the wound. Endoscopic hemostatic clips are usedto stop internal bleeding due resulting from surgical procedures and/ortissue damage from disease, etc. Specialized endoscopic hemostaticclipping devices are used to bring the clips to the desired locationwithin a patient's body and to position and deploy the clip at theappropriate place on the tissue. The clipping device is then withdrawn,leaving the clip within the patient. Such hemostatic clipping devicesare described in U.S. patent application Ser. No. 10/647,512, filed onSep. 30, 2003, and Provisional U.S. Patent Application Ser. No.60/518,167 which are hereby incorporated herein by reference in theirentirety.

Endoscopic hemostatic clipping devices are designed to reach affectedtissues deep within a patient's body, such as within the GI tract, thepulmonary system, the vascular system or within other lumens and ducts.During the procedures to treat those areas, an endoscope is generallyused to provide access to and visualization of the tissue which is to betreated. The clipping device may, for example, be introduced through aworking lumen of the endoscope. The design and construction of such a“through the scope” endoscopic hemostatic clipping device presentsseveral challenges. The endoscopic clipping device has to besufficiently small to fit in the lumen of an endoscope and, at the sametime, must be designed to provide for the positive placement andactuation of the hemostatic clip. Feedback to the operator is preferablyalso provided so that the operator will not be confused as to whetherthe hemostatic clip has been properly locked in place on the tissue andreleased from the device before the device itself is withdrawn throughthe endoscope.

FIG. 1 shows a side elevation view of a through the scope hemostaticclipping device according to an exemplary embodiment of the presentinvention. This device is a hand operated tool that is used to insert ahemostatic clip through an endoscope lumen, position the clip over awound, clamp it and deploy it over the affected tissue. The tool isfurther designed to release the hemostatic clip once it has been clampedin place, and to be withdrawn through the endoscope. To more clearlyexplain the operation and construction of the exemplary device, it maybe divided into three principal components. As shown, the hemostaticclipping device 100 comprises a handle assembly 102, a shaft section104, and a clip assembly 106. The clip assembly 106 is shown moreclearly in FIG. 1A.

Handle assembly 102 forms the component that supplies a mechanicalactuation force to deploy and clamp the clip. In this embodiment, thedevice is hand operated (i.e., the user's hands provide the forcerequired to carry out all the functions related to the hemostatic clip).The handle assembly 102 may be constructed in a manner similar toconventional handle assemblies of the type generally employed inendoscopic biopsy devices or in similar applications. The handleassembly 102 allows the user to move a control wire 118 or other forcetransmission member, which extends through the shaft section 104 to theclip assembly 106 at a distal end of the device 100. The handle assembly102 comprises a handle body 108 which can be grasped by the user tostabilize the device and apply a force to it. A sliding spool 110 isconnected to control wire 118, so that the user can easily pull or pushsaid wire 106 as desired.

As shown in FIGS. 1 and 2, a sliding spool 110 is mounted on the handlebody 108 so that it can slide along a slot 116, which maintains itsposition within the handle assembly 102. Because the sliding spool 110is connected to the control wire 118, the user may manipulate thecontrol wire 118 by grasping the handle body 108 and moving the slidingspool 110 along the slot 116. A return spring 112 may be provided withinthe handle body 108 to bias the sliding spool 110, and thus the controlwire 118 toward a desired position. In the present embodiment, thesliding spool 110 is biased to the proximal position. The handleassembly 102 may also include a connection portion 114, which receivesthe control wire 118 and attaches the shaft section 104 to the handleassembly 102.

The shaft section 104 mechanically connects the handle assembly 102 tothe clip assembly 106 and, together with the clip assembly 106, isdesigned to be inserted into a lumen of an endoscope. As shown in FIGS.3 and 4, the shaft section 104 comprises an outer flexible coil 130which is designed to transmit a torque from the proximal end to thedistal end of the device 100 and to provide structural strength to theshaft section 104. The coil 130 may be a conventional coil used inbiopsy devices and may, for example, comprise a single, coiled wire. Thecoiled wire may have a round, square or a rectangular cross section, andmay be made of a biocompatible material such as, for example, stainlesssteel. Additional protective and low friction outer layers may beincluded on the shaft section 104, according to known methods ofconstruction.

The control wire 118 transmits mechanical force applied to the handle102 to the clip assembly 106. The control wire 118 has a proximal endwhich is attached to a movable part of the handle 102, such as thesliding spool 110, using known methods. Stainless steel or other highyield biocompatible materials may be used to manufacture the controlwire 118, so that the structural integrity of the assembly ismaintained. It is also important to prevent stretching of the controlwire 118 when under tension since, if the wire stretches, the handle 102will have to travel a greater distance to carry out a desired operation.As shown in FIG. 5, the distal end of the control wire 118 ends in aball 140 which is used to connect the control wire 118 to theappropriate elements of the clip assembly 106, as will be describedbelow. In this embodiment, the diameter of the control wire 118 issubstantially constant from a proximal end thereof to a proximal end ofa distal tapered section 144. The ball 140 may have a diameter which isgreater than the diameter of the control wire 118, to facilitateattachment to a yoke 204. The control wire 118 may extend the length ofthe device 100, from the yoke 204 to the sliding spool 110, and may bedesigned to slide longitudinally along the device 100. It may be made,for example, of stainless steel or other biocompatible metal.

The control wire 118 may also include a reduced diameter section 142designed to fail when a predetermined tension is applied thereto throughthe handle assembly 102.

The tapered section 144 may be used to transition between the main bodyof the control wire 118 and the reduced diameter section 142, withoutsteps or other discontinuities which may concentrate stress and make thefracture point more unpredictable. As will be described in greaterdetail below, one purpose of the reduced diameter section 142 is tofacilitate the release of a hemostatic clip from the hemostatic clippingdevice 100 once the clip has been properly deployed. It will be apparentto those of skill in the art that the location of the reduced diametersection 142 the along control wire 118 may be varied to take intoaccount specific requirements of the device 100.

An inner sheath 132 may be used in the construction of the shaft section104, as shown in FIGS. 3 and 4. The inner sheath 132 provides a lowfriction bearing surface disposed between the outer diameter of thecontrol wire 118, and the inner diameter of the shaft section 104. Theinner sheath 132 may be formed of a low friction material such as, forexample, Teflon™, HDPE or Polypropylene. In one exemplary embodiment,the inner sheath 132 is slidable within the shaft section 104, and thecontrol wire 118 is slidable within the inner sheath 132 forming a lowfriction system of multiple bearing surfaces. To further reducefriction, a bio-compatible lubricant may be applied to the inner andouter surfaces of the inner sheath 132, along the length of the shaftsection 104. For example, silicone lubricants may be used for thispurpose.

A slidable over-sheath 150 may be included in the design of the shaftsection 104, as shown in FIGS. 1 and 2. The over-sheath 150 is designedto protect the inner lumen of the endoscope from the metal clip assembly106 and from the metal coil 130 while the hemostatic clipping device 100passes through the endoscope's lumen. After the clipping device 100 and,more specifically, after the clip assembly 106 has passed through theendoscope, the over-sheath 150 may be withdrawn to expose the distalportion of the clipping device 100. The over-sheath 150 may be formed,for example, as a single lumen plastic extrusion element slidable overthe distal portions of the clipping device 100 to selectively cover anduncover the clip assembly 106. In one embodiment, the over-sheath 150 isformed of a low friction polymer such as, for example, Teflon′, HDPE,Polypropylene, or similar materials.

The over-sheath 150 may include a grip portion 152 and an elongated body154. The grip portion 152 is designed as a handle making it easier forthe user to slide the over-sheath 150 over the shaft of the clippingdevice 100. In one exemplary embodiment, the grip portion 152 is made ofa rubber-like material to provide a good gripping surface for the user.For example, an injection moldable polymer such as TPE may be used toconstruct the grip portion 152. The elongated body 154 may be formed asa substantially cylindrical shell surrounding the shaft of the clippingdevice 100. The elongated body 154 may be attached to the grip portion152 using conventional methods as would be understood by those skilledin the art.

As shown in FIGS. 6 and 7, an exemplary grip portion 152 comprises acentral hollow channel 160 that may be used to receive the shaft of theclipping device 100. The central hollow channel 160 is aligned with theelongated body 154 to provide a continuous channel containing the shaftof the clipping device 100. The material of the grip portion 152 mayhave a high coefficient of friction, so that an interference fit ispossible between the central hollow channel 160 and the shaft of theclipping device 100 without the use of adhesives or mechanical fasteningdevices. In one embodiment, friction bosses 158 may be provided on aninner diameter of the hollow channel 160 to provide additional frictionbetween the shaft of the clipping device 100 and the over-sheath 150assembly. The friction bosses 158 may be formed, for example, asprotrusions extending from the inner diameter of the over-sheath 150 andmay have a variety of stubby or elongated shapes. The amount of frictionbetween these two components may be balanced so that no unwantedrelative movement takes place while, at the same time, making itrelatively easy for the user to slide the over-sheath 150 proximally anddistally when necessary.

A sheath stop 156 may be provided for the clipping device 100 to preventthe over-sheath 150 from sliding away from the distal end while theclipping device 100 is inserted in the endoscope. As shown in theexemplary embodiment of FIGS. 2 and 8, the sheath stop 156 physicallyblocks the grip portion 152 from sliding proximally to prevent theover-sheath 150 from being withdrawn and exposing the clip assembly 106.The sheath stop 156 is designed to easily snap in place near theproximal end of the shaft section 104 where it can be reached andmanipulated by the operator during the surgical procedure. Once the clipassembly 106 has been inserted in the endoscope and has reached thedesired location in the patient's body, the sheath stop 156 may beremoved from the shaft section 104 so that the user can move the gripportion 152 proximally to uncover the clip assembly 106.

The connection between the sheath stop 156 and the shaft section 104 mayinclude, for example, pairs of opposing fingers 162, 164 that aredesigned to snap over the shaft section 104. The fingers 162, 164cooperate to securely and releasably hold the body of the shaft section104 therebetween. The fingers 162, 164 respectively comprise guideportions 170, 172; shaft channel portions 166, 168; and blockingportions 174, 176. Insertion of the sheath stop 156 on the elongatedbody 154 is accomplished by pressing the body of the shaft section 104between the guide portions 170, 172, to spread the fingers 162, 164 andallow further insertion of the shaft 104 between the fingers 162, 164.The guide portions 170, 172 and the blocking portions 174, 176 areshaped so that insertion of the shaft section 104 towards the channelportions 166, 168 requires less effort than moving the shaft section 104in the opposite direction.

Once shaft section 104 has been placed within the channel portions 166,168, the fingers 162, 164 snap back to their non-spread position andretain the shaft section 104 in place therebetween. The shaft section104 is removed by pulling the sheath stop 156 away from the shaftsection 104. Due to the shape of the blocking portions 174, 176,removing the shaft section 104 requires the application of more forcethan does insertion thereinto. Stops 180 may also be provided on thesheath stop 156 to limit the movement of the shaft section 104 towardsthe grasping portion 161 to prevent damage to the device that may becaused by excessive spreading of the fingers 162, 164. The sheath stop156 may be formed of a resilient material, such as a polymer, and may bemanufactured by injection molding.

The clip assembly 106 is disposed at the distal end of the clippingdevice 100, and contains the mechanism that converts the proximal anddistal movement of the control wire 118 into the actions necessary todeploy and release a hemostatic clip 90. FIGS. 9, 10 and 11 show,respectively, side, top and perspective views of the distal end of theclipping device 100, including the clip assembly 106 having clips in thefolded configuration. This configuration is used, for example, to shipthe clipping device 100 and to insert the clipping device 100 throughthe lumen of an endoscope. Some of the components of the clip assembly106 include a capsule 200 which provides a structural shell for the clipassembly 106, the clip arms 208 which move between open and closedpositions, a bushing 202 attached to the distal end of the control wire118, and a yoke 204 adapted to connect the capsule 200 to the controlwire 118.

As depicted, the proximal end of the capsule 200 slides over the distalend of the bushing 202. A locking arrangement between these twocomponents is provided by capsule tabs 212, which are designed to lockinto the bushing 202 so that mechanical integrity is temporarilymaintained between the capsule 200 and the bushing 202. Within thecapsule 200 are contained a yoke 204 and a tension member 206 whichtransmit forces applied by the control wire 118 to the clip arms 208.The ball 140 formed at the distal end of the control wire 118 is matedto a receiving socket 210 formed at the proximal end of the yoke 204. Amale C-section 214 extending from the tension member 206 is received ina corresponding female C-section 216 formed in the yoke 204, so that thetwo components are releasably connected to one another, as will bedescribed below. The clip arms 208 in the closed configuration have aradius section 300 which is partially contained within the capsule 200to prevent opening of the arms. Each of the clip arms 208 goes over thetension member 206 and has a proximal end 222 which slips under a yokeoverhang 254, to further control movement of the arms 208.

FIGS. 12 and 13 show a top and a perspective view of one exemplaryembodiment of the clip assembly 106 in an open configuration with theclip arms 208 in a fully open position. The open configuration isobtained when the sliding spool 110 shown in FIG. 1 is moved distally sothat the ball 140 of the control wire 118 pushes the assembly containingthe yoke 204 and the tension member 206 forward, sliding within thecapsule 200. As will be described below, the distal ends of the cliparms 208 are biased toward the open position and revert to this positionwhenever they are not constrained by the capsule 200. In the exemplaryembodiment, a maximum opening of the clip arms 208 occurs when the cliparms 208 ride over the folded distal folding tabs 220 which extend fromthe distal end of the capsule 200, as shown in FIGS. 14 and 15. In thisembodiment, the tabs 220 provide a cam surface, and the clip arms 208act as cam followers, being deflected by the tabs 220. In addition, thefolding tabs 220 may also provide a distal stop for the tension member206, to retain it within the capsule 200. Thus, by moving the slidingspool 110 distally, the user opens the clip arms 208 to prepare to grasptissue therebetween.

When the sliding spool 110 is moved proximally by the user, the assemblywithin the capsule 200 also moves proximally and the clip arms 208 arewithdrawn within the capsule 200. As the clip arms 208 move proximallywithin the capsule 200, clip stop shoulders (CSS) 222 contact a distalportion of the capsule 200, for example, the folded tabs 220. Thisinteraction of the CSS 222 with the capsule 200 provides to the user afirst tactile feedback in the form of increased resistance to movementof the sliding spool 110. This feedback gives to the operator a positiveindication that further movement of the handle control will cause thehemostatic clip 90 to be deployed from the clip assembly 106. Theoperator may then decide whether the current position of the clip 90 isacceptable or not. If the position is acceptable, the operator candeploy the clip 90 by continuing to move the sliding spool 110 withincreased proximal pressure to cause the clip arms 208 to close on thetissue. If not, the operator can move the sliding spool 110 distally tore-open the clip arms 208 and extend them out of the capsule 200,reposition the clip 90, and repeat the above steps to close the clip 90at a more appropriate location.

When the user determines that the clipping device 100 is positionedcorrectly, the proximal pressure on the sliding spool 110 may beincreased to continue deployment of the hemostatic clip 90 from the clipassembly 106. FIGS. 16 and 17 show respectively a top and side view ofthe clipping device 100 in this condition. As the proximal tension onsliding spool 110 is increased, the control cable 118 pulls the yoke 204proximally, away from the tension member 206. The tension member 206 isfirmly attached to the clip arms 208 which are prevented from movingproximally by the interaction of the CSS 222 with the folded tabs 220.If sufficient pulling force is applied to the yoke 204, the male Csection 214 of the tension member 206 yields and loses integrity withthe female C section 216 of the yoke 204. This can occur because, in theexemplary embodiment, the tension member 206 is formed of a materialwith a lower yield strength than the material of the yoke 204.

The force required to break the tension member 206 away from the yoke204 may be tailored to achieve a desired feedback that can be perceivedby the user. The minimum force required to break the tension member 206free of the yoke 204 may be selected so that a tactile feedback is feltby the user, to prevent premature deployment of the hemostatic clip 90while a maximum force may be selected so that other components of thelinkage between the sliding spool 110 and the clip arms 208 do not failbefore the male C section 214 and the female C section 216 disconnectfrom one another. In one exemplary embodiment, the tension forcenecessary to disconnect the two components may be in the range ofapproximately 4 lbf to about 12 lbf. This range may vary depending onthe size of the device and the specific application. To obtain thisforce at the interface of the male and female C sections 214, 216 alarger force will be applied by the user at the sliding spool 110, sincefriction within the device may cause losses along the long flexibleshaft.

When the male C section 214 of tension member 206 yields, several eventstake place within the exemplary device 100 nearly simultaneously. Morespecifically, the yoke 204 is no longer constrained from movingproximally by the CSS 222 abutting the capsule 200. Thus the yoke 204travels proximally until coming to rest against a distal bushingshoulder 250. The tension member 206 is not affected by this movementsince it is no longer connected to the yoke 204. The proximal ends 252of the clip arms 208 are normally biased away from a center line of thedevice 100 and are no longer constrained by the yoke overhangs 254.Accordingly, the clip latches 302 are free to engage the latch windows304 of the capsule 200, thus maintaining the integrity of thecapsule-clip arms combination after deployment. Details of one exemplaryembodiment of the capsule 200 are shown in FIGS. 14, 15 and details ofthe clip arms 208 are shown in FIGS. 18, 19 and 20.

As the yoke 204 moves proximally to abut against the bushing 202, thecapsule tabs 306 are bent away from the centerline of the capsule 200 bythe cam surfaces of the yoke 204. As a result, the capsule tabs 306 areno longer engaged to the corresponding bushing undercuts 350, shown inthe side and perspective views of the bushing 202 depicted in FIGS. 21,22. Since the capsule 200 and the bushing 202 (which is securelyconnected to shaft section 104) are no longer connected, the clipassembly 106 is prevented from being released from the shaft section 104only by its connection to the ball 140 of the control wire 118.

A further result of moving the yoke 204 against the distal bushingshoulder 250 of the bushing 202 is that the distal end of the wire stop360 (shown in FIGS. 12, 16) is placed near the proximal bushing shoulder364 (shown in FIG. 22). The flared fingers 362 located at the distal endof the wire stop 360, better shown in FIG. 23, are compressed as theypass through the central ID of the bushing 202, but return to theirnormally biased open position (shown in FIG. 23) after passing past theproximal bushing shoulder 364. Further distal movement of the slidingspool 110 is thus prevented since that movement would engage the fingers362 of the wire stop 360 with the proximal bushing shoulder 364. Thisfeature prevents the clip assembly 106 from being pushed away from thebushing 202 before the ball 140 is separated from the control wire 118,as will be described below.

The wire stop 360 comprises a tube with a first slotted and flared endattached to the control wire 118 by conventional means. As shown in FIG.23, the slots impart flexibility to the device so it can easily passthrough the central lumen of the bushing 202. Flared fingers 362 areformed by the slots, and engage the proximal bushing shoulder 364. Thewire stop 360 is made of a material that is biocompatible and that hasenough resilience so that the fingers 362 re-open after passage throughthe bushing 202. For example, stainless steel may be used for thisapplication.

One feature of the exemplary embodiment of the invention described aboveis that the user receives both tactile and auditory feedback as the clipassembly 106 is deployed and released. The separation of the tensionmember 206 from the yoke 204 produces a small clicking noise and atactile feel that is perceptible while holding the handle assembly 102.The change in axial position of the sliding spool 110 is thus augmentedby the changes in resistance to its movement and by the clicking soundand feel through the start and stop of the movement. As a result theuser is always aware of the status of the clip assembly 106, and theinadvertent deployment of a hemostatic clip 90 in an incorrect locationis less likely. It will be apparent to those of skill in the art thatthe order of male and female connectors in the device may be reversed orchanged without affecting the operation of the device.

It may be beneficial for the user to be certain that the clip assembly106 has been deployed before the rest of the clipping device 100 isremoved from the endoscope. Injury to the tissue being treated couldresult if the clipping device 100 is removed from the operative sitewhen the hemostatic clip 90 is only partially deployed. Accordingly, alarge tactile feedback may be incorporated, to augment the auditory andtactile feedback stemming from the separation of the yoke 204 from thetension member 206. FIG. 24 depicts the condition where the clipassembly 106 separates from the rest of the clipping device 100.According to the described embodiment, this second user feedback isobtained by designing the control wire 118 so that it will separate fromthe end ball 140 when a predetermined tension is applied to it. In otherwords, the ball 140 of the control wire 118 is mechanically programmedto yield and separate from the body of the control wire 118 when apre-set tension is applied thereto. The size of the reduced diametersection 142 can be selected so that, when the user continues to move thesliding spool 110 proximally as the programmed yield tension is reached,the ball 140 detaches from the tapered section 144 and provides a largetactile feedback to the operator.

When the ball 140 detaches, the sliding spool 110 bottoms out at theproximal end of the handle 108, such that a full stroke of the handleassembly 102 is reached. The tension required to cause the reduceddiameter section 142 to yield and release the ball 140 may vary over arange of values. However, for best results the force should be greaterthan the tension force required for the male C section member 214 toseparate from the yoke 204. If this condition is not satisfied, asituation may occur where the clip assembly 106 is locked in place onthe patient's tissue, but cannot be released from the clipping device100. It will be apparent that this situation should be avoided. In oneexemplary embodiment, the tension force required to separate the ball140 from the body of the control wire 118 is in the range of betweenabout 10 lbf and 20 lbf at the distal end of the control wire 118. Asdiscussed above, losses along the elongated flexible shaft may requirethe user to apply a force substantially greater than this to the handlebody 102.

Once the ball 140 has separated from the rest of the control wire 118,the user can pull the rest of the clipping device 100 from theendoscope. As this is done, the yoke 204 is retained within the capsule200 by the spring and frictional forces of various features of thecapsule 200, such as the capsule tabs 306. Prior to withdrawing theclipping device 100, the over-sheath 150 may be moved distally by theuser over the entire remaining portions of the shaft section 104 toprevent damage to the endoscope as the clipping device 100 is withdrawntherethrough. The sheath stop 156 may also be placed on the shaftsection 104 proximally of the over-sheath grip 152 to preventinadvertent sliding of the over-sheath 150 from the distal end of thedevice 100.

A more detailed description of several components of the clipping device100 follows. The clip arms 208 are shown in detail in FIGS. 18, 19 and20; the tension member 206 is shown in side and top views in FIGS. 25,26; while top and side views of the yoke 204 are shown respectively inFIGS. 27 and 28. the clip arms 208 may be formed of a biocompatiblematerial such as Nitinol, Titanium or stainless steel. Maximum springproperties may be obtained by using materials such as 400 seriesstainless or 17-7 PH. As shown, a tear drop keyway 400 is formed in theclip arm 208 to mate with a corresponding tear drop key 402 formed onthe tension member 206. This feature maintains the relative positions ofthese two components and of the yoke 204 substantially constant. Theshape of the keyways 400 may be varied. For example, the keyway 400 maybe oval or elliptical. Central portions of the clip arms 208 define aspring section 404. When the proximal ends 252 of the clip arms 208 areunder the yoke overhangs 254, the clip arms 208 are allowed to pivotover the tension member 206, which in turn biases the distal ends 252towards the open configuration when no longer restrained by the capsule200. As a result, the proximal end 252 of each clip arm 208 springsupward and engages the latch windows 304 in the capsule 200.

the clip arms 208 also comprise a radius section 300 that adds strengthto the clip and reduces system friction. The radius of the radiussection 300 approximately matches the inner diameter of the capsule 200and has a smooth profile to avoid scratching the inner surface of thecapsule 200. A pre-load angle α is defined between the radius section300 and the spring section 404. The pre-load angle α determines how muchinterference (pre-load) exists between the two opposing clip arms 208 attheir distal ends when closed. The greater the pre-load angle α, thegreater the engaging force that is applied by the clip arms 208.However, this condition also causes the greatest system friction whenthe hemostatic clip 90 is closed. The clip arms 208 also compriseinterlocking teeth 408 disposed at their distal ends. In the exemplaryembodiment, the teeth 408 are identical so that the arms may beinterchangeable and will mesh smoothly with the set facing them. Theteeth 408 are disposed at a nose angle β which may be betweenapproximately 90 and 135 degrees, but in other applications may begreater or lesser than the described range.

One exemplary embodiment of the capsule 200 is shown in detail in FIGS.14 and 15 and comprises alignment keyways 500 that are designed to matewith corresponding features on the bushing 202 to rotationally align thetwo components. In this embodiment, the capsule tabs 306 may be benttowards the centerline of the capsule 200 to engage the bushingundercuts 350. The engagement maintains the integrity between thecapsule assembly 200 and the rest of the clipping device 100 until theyoke is pulled into the distal bushing shoulder. the capsule overhangs502 provide added clamping strength to the deployed clip arms 208. Thisis achieved by reducing the length of the portion of each clip arm 208that is not supported by a portion of the capsule 200. This feature doesnot affect the amount of tissue that may be captured by the clip arms208 since the capsule overhangs 502 extend on a plane substantiallyparallel to the plane of the clip arms 208.

Additional features of the capsule 200 include an assembly aid portwhich may be used to assist in aligning the components of the clipassembly 106. Bending aids 506 facilitate a smooth bend when the distalfolding tabs 220 are bent inward, as described above. The bending aids506, as shown, are holes aligned with the folding line of the tabs 220,but may also include a crease, a linear indentation, or other type ofstress concentrator. The capsule 200 may be formed from any of a varietyof biocompatible materials. For example, stainless steel, Titanium orNitinol or any combination thereof may be used. High strength polymerslike PEEK™ or Ultem™ may also be used to form the capsule 200, with aheat set treatment being used to adjust positionable elements.

FIGS. 25 and 26 depict additional details of the tension member 206. Asshown, tear drop keys 402 are designed to engage the tear drop keyways400 of the clip arms 208, as described above. Clip follower planes 508are shaped to form a fulcrum which allows the clip arms 208 to rockbetween the open and closed configurations. The tension member 206comprises a distal stop face 510 which abuts the distal folding tabs 220of the capsule 200 to stop the distal motion of the capsule assembly106. In general, all surfaces and edges of the tension member 206 thatare in contact with the inner surfaces of the capsule 200 preferablyhave a radius substantially similar to an inner radius of the capsule200 to provide a sliding fit therein. The tension member 206 may beformed of a biocompatible polymer, monomer or thermoset. The type ofmechanism selected to release the tension member 206 from the yoke 204may determine the type of material used since a release due to fractureof the male C section 214 requires a relatively brittle material whilerelease due to yielding without fracture calls for a softer material.

Additional details of the yoke 204 are shown in FIGS. 27-29. When thecontrol wire 118 is seated in the yoke 204, it is desirable to ensurethat it cannot inadvertently be removed from the control wire slot 600.Accordingly, in the present embodiment the ball cavity 602 has adiameter sufficiently large to allow the ball 140 to pass therethroughwhile the wire cavity 604 is large enough to allow the control wire 118to pass therethrough, but not large enough to allow the ball 140 passtherethrough. To assemble the control wire 118 with the yoke 204according to the exemplary embodiment, the proximal end of wire 140 isinserted into the ball cavity 602 until the ball bottoms out, and thenthe control wire 118 is rotated until it is seated in the control wirecavity 604, thus constraining further movement of the ball 140.According to the present embodiment, the yoke 204 may be made of abiocompatible metal such as stainless steel or a high strength polymersuch as Ultem™.

According to embodiments of the present invention, the clipping device100 may be scaled to fit the requirements of different surgicalprocedures. In one exemplary embodiment, the clipping device 100 may besized to fit through an endoscope having a working channel diameter ofapproximately 0.110 inches. The exemplary bushing may have a length ofabout 0.22 inches and an OD of approximately 0.085 inches. The capsulemay have a length of about 0.5 inches, an OD of about 0.085 inches, anda wall thickness of about 0.003 inches. When assembled, the rigid lengthof the capsule 200 and the bushing 202 is approximately 0.625 inches.This length is important because if it is too great, the assembly willnot pass through the bends of the flexible endoscope. In the exemplaryclipping device, the outer sheath may have an ID of approximately 0.088inches and an OD of about 0.102 inches. The overall length of theclipping device may be approximately 160 inches, while the tissuegrasping portion of the clip arms 208 may be approximately 0.4 incheslong.

In treating internal bleeding, and in particular to apply an hemostatictreatment to gastrointestinal bleeding, it is often necessary to applymore than one hemostatic clip to the injured tissue. Using conventionalmethods, the treatment involves repeatedly utilizing a single deploymentclip apparatus, with the disadvantage of having to remove the oldclipping device from the endoscope, prepare additional clipping devices,and re-inserting the additional clipping devices in the endoscope foreach clip. After insertion in the endoscope, each additional device hasto be re-positioned over the wounded tissue before the new clip may bedeployed. Multi deployment clipping devices are also in use, butgenerally require the device to be removed from the endoscope so that anew clip may be loaded manually in the device.

In a further embodiment of the present invention, a multiclip endoscopichemostatic device may be used to discharge multiple hemostatic clipswithout the necessity to remove the device from the endoscope after eachclip is deployed. The multiclip device achieves equal or better resultsthan conventional single deployment clipping devices, while greatlyfacilitating the placement of multiple hemostatic clips in cases where asingle hemostatic clip is insufficient. In one embodiment, the clipsused by the multiclip device according to the present invention aresubstantially similar in size to conventional hemostatic clips, and thuscan be used with conventional endoscopes. According to the invention,the cost of manufacturing the multiclip apparatus is sufficiently low topermit the units to be disposable, and be discarded after use with onlyone patient.

According to the invention, the multiclip hemostatic clipping apparatusis used in a minimally invasive environment, such that it is applied tothe surgical site through an endoscope. The distal end of the hemostaticmulticlip device is inserted through the working lumen of the endoscope,and is brought in the vicinity of the surgical site where the bleedingoccurs. For example, an endoscope having a working channel of at leastabout 1.8 mm inner diameter may be used to reach the surgical site. Theproximal ends of the endoscope and of the hemostatic multiclip deviceare provided with hand controls used by the user/physician to operatethe devices.

The hemostatic multiclip device according to an exemplary embodiment ofthe present invention uses a magazine containing a plurality ofhemostatic clips that is advanced through the endoscope's working lumen,to a location near the surgical site. The magazine may be attached to asheath designed to protect the inner surfaces of the endoscope fromdamage caused by sharp edges of the magazine and clip assembly, andwhich extends beyond the magazine through the length of the endoscope.The hemostatic clips are joined in a clip chain which is inserted in themagazine, and is free to translate in the magazine within certain limitsthat will be described below. Each of the clips may be formed, forexample, of sheet metal or of another material having appropriatemechanical and bio-compatibility properties. The material of the clipsis selected to resist plastic deformation while constrained in theclosed configuration, so that the hemostatic clips will return to theopen configuration when not otherwise restrained.

A modified version of the clipping device 100, shown in FIGS. 1 and 2,may be used with the clip magazine and clip chain described above. Aclip magazine containing multiple hemostatic clips may be inserted inthe proximal end of the shaft section 104, such that the clips aredeployed from the distal end thereof. A handle 108 and sliding spool110, or similar implements, may be used in conjunction with a controllinkage to operate the multiclip dispensing apparatus, as will bedescribed in detail below.

FIG. 31 shows an exemplary embodiment of a hemostatic clip according tothe present invention. Exemplary clip 702 comprises two clip arms 704which have inner facing surfaces adapted to grasp and retain tissuetherebetween when placed in a closed configuration. In FIG. 31, the cliparms 704 are in the open configuration which is assumed by the clip 702in the early phase of deployment, before the tissue is clamped. Clip 702may be formed of two parts joined at the common portion 705, or may beof a single piece construction. In the exemplary embodiment, clip 702 isbiased in the open configuration (shown in FIG. 31) prior to beingloaded in the clip magazine. A sliding lock ring 706 may be used to lockclip arms 704 in the closed configuration, which is assumed by the clip702 when it is clamped to the tissue. In different exemplaryembodiments, the sliding locking ring 706 may be replaced by differentdevices adapted to lock clip arms 704 in the closed configuration.

As indicated above, a plurality of clips may be loaded in the magazinefor use with the hemostatic multiclip device according to the presentinvention. FIG. 32 shows an exemplary embodiment of a clip chainaccording to the invention. Clip chain 700 is formed by joininghemostatic clips 702 to one another using, for example, a linkingfeature 708. Linking feature 708 may comprise an attachment whichretains the two joined clips 702 together as long as there is nomovement of the joined clip ends in a direction perpendicular to thelongitudinal axis of the clips. In this manner, the clip chain 700remains intact as long as the clips are translated in a directiongenerally along the longitudinal axis of the clips. One clip may bereleased, however, by moving the appropriate clip end along a diameterof the device, that is in a direction perpendicular to the longitudinalaxis. For example, linking feature 708 may be clamped between the distalends of clip arms 704 which are held in the closed configuration.Linking feature 708 may be formed integrally with the body of hemostaticclip 702, or may be an optional addition that may be attached to moreconventional clips.

An exemplary clip magazine 720 is shown in perspective view in FIG. 36.Clip chain 700 (shown in perspective view in FIG. 35) may be insertedlongitudinally in the hollow channel 722 of magazine 720, as shown inFIG. 38. Magazine 720 may be a generally cylindrical structure locatedat the distal end of the hemostatic multiclip device, which contains aportion or all of the clips 702 within the clip chain 700. Magazine 720,together with clip chain 700, forms a capsule having dimensions andsufficient flexibility to comply with the curvature of the endoscope'sworking channel. Compliance features 723 may be used to impartflexibility to the body of magazine 720, and for example may comprisecircumferential slits. A control link 726 may enter a proximal opening722 of the clip magazine 720, opposite from the distal end 724.

The most proximal of the clips 702 may be connected to control link 726in a releasable manner. Control link 726 may be designed to carrycompression and tension loads, so that clip chain 700 may be translatedin both directions through forces transmitted by control link 726.Control link 726 may be formed by a rigid tube, a semi rigid wire, or byany other structural element capable of transmitting tension andcompression loads along the length of the hemostatic multiclip device.Control link 726 may be connected to a control handle at the proximalend, to give to the surgeon control of the clip's deployment.

FIG. 30 shows a detail of the connection between the control link 726and the most proximal hemostatic clip 702. In this embodiment, controllink 726 is a rod or tube which terminates in a connector portion 727adapted to push against linking element 708. Connector portion 727 mayalso be designed to apply a tension force to the linking element 708, ina known manner. A sheath 725 may be used to encapsulate control link726, to protect the working channel of an endoscope from damage, and toreduce friction between the moving control link 726 and the clipmagazine 720.

A control handle portion of the hemostatic multiclip device (not shown)is provided at the proximal end of the device, extending outside of theproximal end of the endoscope. The control portion may be similar tothat shown in FIG. 1, and may comprise hand controls which operate thecontrol link 726 to cause the deployment and the release of thesuccessive clips 702. For example, hand movements of the surgeon may betransformed within the control portion into longitudinal movements ofthe control link 726 along the working channel of the endoscope. In anexemplary embodiment, clip chain 700 is rigid in compression andsupports tensile loads, at least while contained within the clipmagazine 720. Clip chain 700 can therefore be translated along magazine720 via movement of the control link 726.

As shown in FIG. 38, the clip chain 700 is formed of hemostatic clips702 which remain attached to one another while they are within thecylindrical containment of the clip magazine 720. Clip magazine 720supports and constrains the clips 702 of the clip chain 700 in theradial direction through a large portion of its length. This preventspairs of adjacent clips 702 from disconnecting, by not allowing relativeradial movement between two clips. In particular, the radial movement ofthe substantially closed clip arms 704 of a first hemostatic clip isprevented, so that the linking feature 708 of a second clip, adjacent tothe first clip, is not released. The exemplary design of clip chain 700helps to minimize the width of the device, since it is only as wide asthe width of the clips themselves.

The diameter of clip chain 700 works in conjunction with the shape ofthe distal end 724 of clip magazine 720 to control the position of thedistal portion of clip chain 700 through the distal end 724. As shown inFIG. 37, magazine 720 has a reduced cross section portion 730 designedto limit the diameter of what passes therethrough. Specifically, reducedcross section 730 allows the passage of a single clip unattached toanother clip at its distal end. However, reduced cross section 730 doesnot allow passage of a pair of connected clips. This is because thediameter of two connected clips is greater than the diameter of a singleclip. In the exemplary embodiment that is due to the clip arms 704 notclosing fully when they lock unto the linking feature 708 of anotherclip 702, resulting in a greater distal tip diameter of the clip.

The function of the clip chain 700 is better shown in FIGS. 39, 40,where a clip 702′ is placed to lead the clip chain 700 through thedistal end 724 and through cross section reduction 730. As the controlelement 726 is pushed distally, clip chain 700 is pushed distally untilits second most distal clip 702 is stopped by reduced cross section 730,at a position where the most distal clip 702′ is outside of magazine720, and is biased in the open configuration ready to grasp the tissue.In FIG. 39, the most distal hemostatic clip 702′ is being pushed outsideof clip magazine 720, past the distal end 724. As the control link 726continues to push distally, clip arms 704 of the second most distal clip702 of chain 700 abut the reduced cross section 730 (FIG. 40). At thispoint the single distal clip 702′ is largely outside of magazine 720,and its clip arms 704′ take the open configuration since they are nolonger constrained by magazine 720.

Once the user has placed the open clip 702′ over the desired location onthe tissue, control link 726 is pulled proximally, so that clip chain700 (including the most distal clip 702′) is pulled back into magazine720, as shown in FIG. 41. Clip sliding lock ring 706 is held distally bylock ring anti-pull back tabs 734, as distal clip 702′ is pulledproximally. This causes lock ring 706 to move partially over clip arms704′ and lock them in the closed configuration, to firmly grasp thetissue held within clips arms 704′. At this point the most distalhemostatic clip 702′ is clamped securely over the tissue, but is stillattached via linking feature 708 to the clip chain 700.

After deployment and clamping of the most distal hemostatic clip 702′ isachieved, further proximal movement of the control linkage 726 causesseparation of clip 702′ from clip chain 700. Additional features may beformed on the clip 702′ or on the lock ring 706 to cooperate with distalend 724 and prevent further proximal movement of the distal clip 702′relative to magazine 720. The pull back distance of distal clip 702′ maybe controlled, for example by properly positioning the additionalfeature 733, so that the link between the most distal clip 702′ and thenext to most distal clip 702 is located in a relief portion 732 of thedistal end 724. Relief portion 732 may be a movable tab or opening whichallows local diametrical expansion of the clips within that portion ofmagazine 720.

As continued proximal tension force is applied by control link 726, cliparms 704 of the second most distal clip 702 are pushed diametricallyoutward over the interlock feature 708 of the most distal hemostaticclip 702′, which now acts as a cam surface. Relief portion 732 of theclip magazine 720 allows the outward expansion due to the outwardmovement of clip arms 704 over linking feature 708, thereby permittingclip arms 704 to continue moving proximally and separate fromdistal-most clip 702′. In other words, the separation of the twoadjacent clips is caused by the force in the diametrical directionresulting from clip arms 704 being forced over clip lock feature 708 ofdistal clip 702′, and this force overcoming the bias of relief portion732. Distal most clip 702′ is still prevented to further move proximallyby the additional feature 733 described above, but is now free to movedistally and exit magazine 720.

FIG. 42 depicts the situation where the “former” most distal hemostaticclip 702′ has been ejected from clip magazine 720, and is clampedsecurely to the target tissue. A “new” most distal hemostatic clip 702has been pushed partially out of magazine 720, and its clip arms 704 arein the open configuration, outside of distal portion 724. The new mostdistal clip 702 is still connected to another clip 702 which is fullyinside of clip magazine 720, and is part of clip chain 700. The user mayat this point position open clip arms 704 over the desired tissue, andrepeat the process described above to clamp clip arms 704 over thetissue, lock them closed, and release the new distal-most clip 702 fromthe clip chain 700 and from clip magazine 720.

To release the most distal clip 702′ from the clip chain 700, the cliparms 704 belonging to the clip 702, adjacent to the clip 702′, have todisengage from the linking feature 708′. To do so, the distal tip ofclip arms 704 has to open at least sufficiently to clear the linkingfeature 708′ of the most distal clip 702′. The clip 702 is containedwithin the magazine 720, which because of its radially rigidconstruction, for the most part prevents the clip arms 704 from opening.The only time that the clip arms 704 can open and release the linkingfeature 708′ is when the distal tips 705 of the clip arms 704 aresubstantially aligned with a section of the magazine 720 which either isradially wider, or is designed to yield when pressed by the clip arms704. For example, the relief portion 732 may comprise a cut out openingor a non-rigid portion of the magazine's wall, dimensioned toaccommodate the tips 705 of the clip arms 704.

The utility of the multi clip deployment device according to theinvention may be increased by configuring the multi-clip magazine sothat the release of the linking feature 708′ from clip arms 704 can beperformed more easily. In an additional exemplary embodiment shown inFIG. 43, the magazine 800 is formed with an expanded section 804 whichextends 360 degrees around the circumference of the magazine 800. Theexpanded section 804 formed by the wall of the magazine 800 defines anexpanded chamber 810 within the lumen of magazine 800. The expandedchamber 810 provides for sufficient room within the magazine 800 toallow distal tips 705 of the clip arms 704 to move radially outwards, asthe clip arms 704 open to pass over the linking feature 708′.

The deployment of the most distal clip 702′ from the exemplary magazine800 is in many respects similar to the deployment from the magazine 720,described above. A control link 726 may be used to transfer commandsfrom the surgeon to the clip deployment mechanism in the form ofproximal and distal translation of the link 726. The most distal clip702′ is initially connected to a clip chain 700, and may be translatedforward and backwards while still connected to the adjacent clip 702.After the surgeon places the distal end of clip 702′ in position overthe target tissue 822, the most distal clip 702′ is pulled back insidethe magazine 800, so that clip arms 704′ close over a portion 820 of thetarget tissue 822. The lock ring 706′ may be pushed distally by distallip 806 of the magazine 800, to lock the clip arms 704′ in the closedposition around the target tissue portion 820.

After the most distal clip 702′ is clamped and locked in the closedposition around the portion of target tissue 820, further proximalmovement of the clip 702 causes the distal clip 702′ and its adjacentclip 702 to detach. For the purposes of this discussion, clip 702 isreferred to as the next-to-most distal clip. More specifically. Thedistal ends 705 of the adjacent clip's arms 704 partially open to passover the linking feature 708′ of the most distal clip 702′, under thetraction applied by the control linkage 726 which pulls clip 702proximally. As described above, the most distal clip 702′ is preventedfrom moving proximally by the shape of the distal end 806 of themagazine 800, so that a tension exists between the most distal clip 702′and the next-to-most distal clip 702. As the clip 702 moves proximally,linking feature 708′ acts as a cam forcing the clip arms 704 to open.The expanded chamber 810 allows the radial opening of the clip arms 704,which releases the linking feature 708′.

The magazine 800 provides several benefits to the multi-clip deploymentdevice according to the present invention. Since the expanded section804 is a radial bulge which spans 360 degrees around the circumferenceof the magazine 800, the rotational orientation of the clip chain 700,which includes clips 702 and 702′, within the magazine 800 is notimportant. The surgeon therefore has greater liberty to orient thedistal clip 702′ as necessary to best perform the procedure. Therotational orientation of the clip chain 700 may be changed relative tothe orientation of the magazine 800 and of the entire multi-clipdelivery device to which the magazine 800 is attached, to better alignthe clip with the target tissue. This configuration simplifies the clipdeployment procedure and makes the entire procedure simpler and lesstime consuming. In addition, manufacturing of the magazine 800 can besimpler, since there is no need to process the magazine to form radialrelief regions such as relief portions 732, or to cut openings in thewall of the magazine 800.

An exemplary clip deployment sequence from a magazine 800 according tothe present invention is described below. FIGS. 44-48 are used to depictthe deployment of a most distal clip 702′ from the magazine 800. FIG. 44depicts a pre-deployment configuration of the most distal clip 702′ fromthe magazine 800, such that the clip arms 704′ are completely within thedistal portion 802 of the magazine 800. In this configuration, thelinking feature 708′ is being grasped by the clip arms 704 of the clip702, such that the two clips 702, 702′ are connected in the clip chain700. The lock ring 706′ is away from the clip arms 704′, and does notyet constrain them in the closed configuration. In this step of thedeployment, the surgeon may position the distal tip 802 of the magazine800 in proximity of the target tissue, while preparing to clamp the clip702′ to that tissue.

As the control link 726 is pushed distally during a distal stroke of thedeployment sequence, clip 702′ is pushed outside of the magazine 800, asshown in FIG. 45. In this configuration, the arms 704′ of clip 702′ areno longer constrained by the walls of the magazine 800. The lock ring706′ is still near the clip's proximal end, held by the tip 802 withinthe magazine 800, so that the clip arms 704′ are free to move to theopen configuration. At this point, the clips 702, 702′ are connected bymeans of the linking feature 708′, and are free to rotate 360 degrees inany rotational orientation within the magazine 800 to facilitate properorientation relative to the tissue to be clamped. Using the ability toplace the clip 702′ in any desired rotational orientation, the surgeoncan orient the clip arms 704′ in any desired position over the targettissue 820, so that closing the clip arms causes the tissue to beclamped as effectively as possible.

When the clip arms 704′ are correctly placed in the proper orientationover the target tissue 820, the surgeon may continue the deployment bycarrying out a proximal stroke of the deployment sequence. This causesthe control link 726 to move proximally, thus entraining clip 704 andclip 704′. As described in the context of other embodiments, theproximal stroke of control link 726 causes the clip arms 704′ to close,and clamp on the portion 820 of the target tissue 822. Distal end 802 ofthe magazine 800 forces the clip arms 704′ to close as clip 702′ movesproximally inside of the magazine 800, such that the target tissue isclamped, as shown in FIG. 46. The lock ring 706′ is held near distal tip802 by protrusions within magazine 800, and slides distally over theclip arms 704′ as they are pulled proximally within the magazine 800. Inthis manner, the clip arms 704′ are securely locked in the closedconfiguration by ring 706′, and are clamped on the target tissue. Afterthe clip arms 704′ are locked in the closed configuration on the targettissue, the magazine 800 and the rest of the device can be rotatedrelative to the clips 702, 702′, since these are free to turn 360degrees within the magazine 800.

Continued proximal tension on the control link 726 causes the clip 702to further move proximally within the magazine 800. FIG. 47 depicts thisstep of the clip deployment process. However, the most distal clip 702′is prevented from further proximal movement by the lock ring 706′interacting with the protrusions formed at the distal end 802 of themagazine 800. Lock ring 706′ is also prevented from moving too fardistally over the closed clip arms 704′ by ring stops 705. Accordingly,clip arms 704 are pushed apart by the linking feature 708, which acts asa cam as the tip of clip arms 704 pass over it. The expanded chamber 810defined by the expanded section 804 of magazine 800 gives sufficientroom to the clip legs 704 to open and pass over the linking element708′, so that the clip 702 can disengage from the clip 702′. Expandedsection 804 extends 360 degrees around the circumference of the magazine800, so that the orientation of clips 702, 702′ within the magazine 800is not important. This makes it possible for the surgeon to change therotational orientation of the clip 702′ relative to the magazine 800throughout the deployment steps, to maintain the desired orientationbetween the clip 702′ and the target tissue 822.

FIG. 48 depicts the final step of the clip deployment sequence, in whichthe clip 702′ is released from the magazine 800 and is left clamped tothe target tissue. In this step, control link 726 may be again moveddistally, to push clips 702 and 702′, which are now disconnected. Asshown, clip 702′ is pushed outside of the magazine 800 by the distalportion of clip 702, until it is ejected from the magazine 800. Clip 702now becomes the most distal clip present in the magazine 800, and thesame steps described relative to carry out the deployment of clip 702′may be repeated to deploy the new clip 702. Although the drawings depicta magazine 800 containing only two clips 702 and 702′, it will beapparent to those of skill in the art that additional clips may beconnected in the same manner within magazine 800, to form a longer clipchain 700.

As described, the distal most clip 702′ after release from the clipchain 700, or more simply from clip 702, may exit clip magazine 800 dueto the tension applied to it by the clamped tissue. Alternatively, clip702′ may be pushed out by the distal movement of clip 702, as it ispushed towards the distal end 802. The surgeon may ensure a completerelease of clip 702′ by causing the control link 726 to move distally,for example by manipulating the hand control of the device. Conventionalmethods may be used to transform the hand movements of the surgeon intotranslation of the control link 726, and to carry out the initial distalstroke and the subsequent proximal stroke.

The present invention has been described with reference to specificexemplary embodiments. Those skilled in the art will understand thatchanges may be made in details, particularly in matters of shape, size,material and arrangement of parts without departing from the teaching ofthe invention. Accordingly, various modifications and changes may bemade to the embodiments without departing from the broadest scope of theinvention as set forth in the claims that follow. The specifications anddrawings are, therefore, to be regarded in an illustrative rather than arestrictive sense.

1-31. (canceled)
 32. A method for deploying multiple hemostatic clips,comprising: positioning a distal end of a magazine containing a clipchain over selected target tissue; actuating a control link of themagazine in a distal stroke to open and distally translate a distal-mostclip of the clip chain; orienting the open distal-most clip in a desiredorientation to grasp the target tissue; actuating the control link in aproximal stroke to close and lock the distal-most clip over the targettissue; further actuating the control link in the proximal stroke tomove a next clip immediately proximal to the distal-most clip into anexpanded portion of the magazine sized to allow the next clip to open toa degree sufficient to release the distal-most clip from the clip chainregardless of a circumferential orientation of the next clip; andreleasing the distal-most clip by partially opening the next clip. 33.The method according to claim 32, further comprising rotating thedistal-most clip relative to the magazine to a desired orientationrelative to the target tissue.
 34. The method according to claim 32,further comprising camming the next clip over a linking feature of thedistal-most clip during the proximal stroke.
 35. The method according toclaim 32, further comprising opening the next clip in the expandedportion to a degree corresponding to a dimension of the linking feature.36. The method according to claim 32, further comprising closing andlocking the distal-most clip by constraining clip arms of thedistal-most clip and by translating a locking ring over the clip armsusing a distal portion of the magazine.
 37. The method according toclaim 32, further comprising rotating the clip chain to a desiredorientation when releasing the distal-most clip.
 38. The methodaccording to claim 32, further comprising releasing the distal-most clipby opening clip arms of the next clip to a degree sufficient to passover a linking feature of the distal-most clip.
 39. The method accordingto claim 32, further comprising actuating the control link bymanipulating a hand control operatively connected to the control link.40. The method according to claim 32, wherein a diameter of the expandedchamber corresponds substantially to a dimension of the next clip whenpartially opened to release a linking feature of the distal-most clipand wherein the linking feature operates as a cam to open clip arms ofthe next clip.
 41. The method according to claim 32, wherein the linkingfeature comprises an increased diameter protrusion disposed proximallyon the clip.
 42. The method according to claim 32, wherein the clipchain comprises clips designed to assume an open configuration when notconstrained.
 43. The method according to claim 32, wherein the distalportion of the magazine is adapted to lock the distal-most clip bypositioning a locking ring around clip arms of the distal-most clip andwherein the locking ring is movable between a locked position over theclip arms, and an unlocked position distant from the clip arms.
 44. Themethod according to claim 32, wherein the expanded portion comprises acircumferential bulge of the shell having a radius increased withrespect to other portions of the shell.
 45. The method according toclaim 32, wherein the expanded portion extends circumferentially aroundthe shell and wherein the circumferential bulge has a radiussubstantially corresponding to a dimension of the next clip when openedsufficiently to release the distal-most clip.
 46. The method accordingto claim 32, wherein the expanded portion is symmetrical with respect toa longitudinal axis of the multi clip magazine.